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Recruiting NCT06522022

PTSD Screening in Pregnant Black Women

No phase Interventional Pregnancy Early PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturally Responsive SBIRT for OB, Brief Screening for PTSD.
Who it may be relevant to
Registry conditions: Pregnancy Early, PTSD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparing Two Screening Approaches for PTSD to Improve Health Outcomes in Pregnant Black Women

Overview

This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

Detailed description

Researchers will examine whether Culturally Responsive Screening, Brief Intervention, and Referral to Treatment (SBIRT) for obstetrics (OB) is more effective in reducing PTSD symptoms compared to brief screening for PTSD. This study will help participating OB clinics to determine the best option for screening for PTSD in Black pregnant persons in their clinic during first-trimester prenatal visits.

The study population will include Black pregnant women receiving medical care in their first trimester of pregnancy. Surveys and chart abstraction will be used in this study to collect data. The approximate study duration for individuals is 4 visits over 12 months.

Interventions

  • Behavioral Culturally Responsive SBIRT for OB
    SBIRT is a well-established enhanced screening preventive intervention model that is feasible and acceptable for use with trauma-exposed patients and in minoritized communities and can be delivered in the OB clinic during a prenatal care visit. The elements include: 1. standardized screening for PTSD and depression using the Primary Care Post Traumatic Stress Disorder Screen (PC-PTSD-5) and the Edinburgh Postnatal Depression Screening (EPDS) that will mirror brief screening practice; 2. explici
  • Behavioral Brief Screening for PTSD
    This well-established 5-minute in-clinic interview includes administration of the PC-PTSD-5, a 5-item PTSD screening tool by trained medical staff (nurse, physician's assistant). Providers receive approximately one hour of training in trauma-informed care and how to administer the screening protocol. This method is regularly used in primary care clinic settings with trauma-exposed veterans and is validated for use in civilian samples, including low-income Black adults utilizing urban safety net

Primary outcome measures

  • PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score [Time frame: Initial OB visit (weeks 1-13), second trimester (Weeks 14 to 27), third trimester (weeks 28-40), and 6-weeks postpartum]
Secondary outcome measures (1)
  • Adequacy of prenatal care utilization (APNCU) [Time frame: 6 weeks postpartum]

Eligibility criteria

Inclusion criteria

  • 18+ years old,
  • Ability to provide informed consent,
  • English-speaking,
  • Willingness to participate in the study,
  • Self-identification as Black or African American,
  • Pregnant and in the first trimester attending initial prenatal care visit,
  • Endorsement of at least one traumatic event in their lifetime.

Exclusion criteria

  • Active suicidality

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Grady Health System — Atlanta
  • Truman Medical Center (TMC) system — Kansas City

Identifiers

NCT: NCT06522022 · STUDY00007909

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗